(72 days)
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.
These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.
The provided document is a 510(k) premarket notification for 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study designed to establish new acceptance criteria and prove performance against them.
Therefore, many of the requested elements for describing an acceptance criteria study are not directly available in this type of document. Specifically, there is no detailed information on a clinical trial or performance study that would generate acceptance criteria and report device performance against them in the format requested.
However, I can extract information related to the device's claims and the type of testing performed to support its safety.
Here's a breakdown of what can be inferred or explicitly stated from the document, acknowledging the limitations inherent in a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present acceptance criteria and reported device performance in a quantitative table as typically seen in a dedicated performance study. The 510(k) process focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. The "performance" here is primarily an assertion that it meets the safety profile and intended use of the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of a clinical performance study with acceptance criteria. The document mentions "Biocompatibility test results presented in Attachment 4," but details like sample size for these biocompatibility tests are not provided in the summary.
- Data Provenance: The biocompatibility testing likely occurred in a laboratory setting. The country of origin for the manufacturing company is the United Kingdom. Whether the biocompatibility data originates from the UK or elsewhere is not specified. The document does not describe retrospective or prospective clinical studies to evaluate performance against acceptance criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" in a 510(k) for a dressing is typically established through regulatory standards, predicate device performance, and laboratory testing for characteristics like biocompatibility, sterility, etc. There's no mention of a test set requiring expert adjudication for a "ground truth" as would be the case for diagnostic accuracy studies.
4. Adjudication Method for the Test Set:
Not applicable for this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or reported in this document. This type of study focuses on improving human reader performance with AI assistance, which is outside the scope of an alginate wound dressing's submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No, this is not relevant for an alginate wound dressing. This concept applies to AI/ML software as a medical device.
7. Type of Ground Truth Used:
For the safety claims, the "ground truth" would be established by:
- Biocompatibility testing standards: These tests (e.g., cytotoxicity, sensitization, irritation) assess the device's interaction with biological systems. The results are compared against established benchmarks for safety, rather than an "expert consensus."
- Predicate device characteristics: Substantial equivalence relies on comparing the new device's materials, design, intended use, and performance claims to a legally marketed predicate device (K953781). The predicate's established safety and effectiveness serve as a form of "ground truth" for comparison.
8. Sample Size for the Training Set:
Not applicable. This document does not describe the development or training of an algorithm or AI system.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of Device Performance (from the document):
While not a quantitative table with pre-defined acceptance criteria, the document states:
- Biocompatibility: "Biocompatibility test results presented in Attachment 4 support the safety of this product for it's stated intended use." This implicitly means the device met accepted benchmarks for biocompatibility.
- Intended Use: The device is deemed "substantially equivalent" to a predicate for its intended use on partial and full thickness wounds with moderate to heavy exudate (e.g., pressure ulcers, venous ulcers, diabetic ulcers, donor sites, trauma wounds, dermal lesions) and to help control minor bleeding. This means its performance in these areas is considered comparable to the predicate.
Key takeaway: This document is a regulatory submission for premarket notification (510(k)), not a detailed performance study with explicit acceptance criteria for a novel device. Its purpose is to demonstrate that the new device is as safe and effective as a previously cleared predicate device, largely through comparison of materials, design, and intended use, supported by general safety testing like biocompatibility.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.